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FDA grants AstraZeneca and Daiichi Sankyo a priority review for their antibodydrug conjugate Datroway (datopotamab deruxtecan) as ...[ Price : $8.95]
Former CDRH branch chief Morris Waxler, who was involved in the original approval of laser eye surgery (LASIK) and later a promine...[ Price : $8.95]
A new GAO report finds FDAs regulatory responsibilities expanded substantially between fiscal years 2008 and 2024, and now it face...[ Price : $8.95]
FDA sends AstraZeneca a complete response letter rejecting approval of its BLA for a subcutaneous formulation of Saphnelo (anifrol...[ Price : $8.95]
FDA warns Mexicos Unomedical Device about Quality System and Medical Device Reporting violations in its production of insulin infu...[ Price : $8.95]
FDA warns Abbott Diabetes Care about Quality System violations in its production of glucose monitoring systems at a facility in Al...[ Price : $8.95]
FDA warns the Lake Oswego, OR-based Kirkman drug manufacturing facility about repeat CGMP violations in its production of finished...[ Price : $8.95]
FDA releases the form FDA-483 with 12 observations from an inspection at the Baxter Oncology drug manufacturing facility in Halle,...